The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a statement in response to the European Commission’s Communication on addressing medicine shortages in the European Union (EU). EFPIA acknowledges the seriousness of medicine shortages, emphasizing the harm caused to patients and the concern among their families and healthcare providers. While innovative medicines account for only 4% of shortages, EFPIA commits to working collaboratively to manage, mitigate, and, where possible, eliminate them.
One aspect that EFPIA particularly supports is the structural measures outlined in the Commission’s plan, focusing on addressing the industrial dimension of medicine shortages in the medium and long term. EFPIA applauds the Critical Medicines Alliance, a platform intended to facilitate coordinated action against shortages and provide structural solutions rather than merely addressing symptoms.
Medicine shortages can arise from various factors, including manufacturing issues, capacity limitations due to long investment lead times, increased demand during public health emergencies, or forecasting errors. EFPIA stresses the importance of tailoring solutions to target the specific root causes of shortages, ensuring they are proportionate and effective in meeting public health needs.
EFPIA highlights the need for collaboration and early information sharing with industry stakeholders to implement the Communication’s actions successfully. The statement cautions against counterproductive measures, such as imposing stockpiling obligations in some EU countries during supply constraints, which could exacerbate shortages elsewhere and undermine the EU’s voluntary solidarity mechanism.
Additionally, EFPIA expresses concerns about legislative proposals, such as requiring prevention plans for all medicines or a six-month notification of shortages, which might divert essential resources and lead to unintended consequences like panic buying without effectively addressing underlying issues.
EFPIA underscores the untapped potential of the European Medicines Verification System (EMVS) in managing shortages. The EMVS provides real-time data on medicine quantities in the supply chain, offering insights into the root causes and locations of shortages. EFPIA advocates for the inclusion of this valuable resource in the Commission’s actions to enhance collective efforts in safeguarding patients from medicine shortages across Europe.
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